Multiple MyelomaHOLANCT02559583
Observational Study in Participants With Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) in Latin America
An observational study of Multiple Myeloma and Leukemia, run by Janssen-Cilag Ltd. at 23 sites in 7 countries.
Trial summary
The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Leukemia, Lymphoid
- What is being tested?
- Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and Non-Hodgkin's lymphoma (NHL)
- How many people
- 5,443 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Jul 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America
Who may be able to join
- Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
- At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
- Participant must sign a participation agreement/informed consent form (ICF)
Who cannot join
- Having one and only one consult in the center
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Brazil6 sites
Study site
Belo Horizonte
Study site
Fortaleza
Study site
Goiânia
Study site
Porto Alegre
Study site
São José do Rio Preto
Study site
São Paulo
Colombia5 sites
Study site
Bogotá
Study site
Bogotá Dc
Study site
Cali
Study site
Floridablanca
Study site
Medellín
Mexico5 sites
Study site
Huixquilucan
Study site
México
Study site
Mexico City
Study site
Monterrey
Study site
Toluca
Argentina3 sites
Study site
Buenos Aires
Study site
Córdoba
Study site
La Plata Lpl Lpl
About this study
Official title: Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma
The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.
Read the detailed description
This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.
- Conditions
- Multiple Myeloma, Leukemia, Lymphoid, Lymphoma, Non-Hodgkin
- Being tested
- Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), Non-Hodgkin's lymphoma (NHL)
- Keywords
- Multiple Myeloma, chronic lymphocytic leukemia, Non-Hodgkin lymphoma
- Medical subject headings
- Multiple Myeloma, Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Lymphocytic Leukemia (CLL)Other
This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.
Multiple Myeloma (MM)Other
This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.
Non-Hodgkin's lymphoma (NHL)Other
This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Lymphocytic Leukemia (CLL) | This is an observational study. Data will be captured for Participant's with diagnosis of Chronic Lymphocytic Leukemia according to hospital records in the questionnaire provided by the Sponsor. Receives: Other: Chronic Lymphocytic Leukemia (CLL) | |
| Participants with Multiple Myeloma (MM) | This is an observational study. Data will be captured for Participant's with diagnosis of Multiple Myeloma (MM) according to hospital records in the questionnaire provided by the Sponsor. Receives: Other: Multiple Myeloma (MM) | |
| Participants with Non-Hodgkin's lymphoma (NHL) | This is an observational study. Data will be captured for Participant's with diagnosis of non-Hodgkin's lymphoma (NHL) data according to hospital records in the questionnaire provided by the Sponsor. Receives: Other: Non-Hodgkin's lymphoma (NHL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Previous Comorbidities
Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.
Measured: 1 year
Number of Participants as per treatment therapy received
Cancer treatment (Chronic Lymphocytic Leukemia [CLL], Multiple Myeloma [MM] and non-Hodgkin lymphoma [NHL]) for all participants is summarized by the number of participants who had any type of surgery or radiotherapy (external radiation or brachytherapy) or other drug treatments.
Measured: 1 year
Overall survival
Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.
Measured: 1 year
Number of Participants with Response to Treatment
Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.
Measured: 1 year
Secondary outcomes (2)
Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)
Incidence of CLL, MM and NHL will be reported. It is a percentage of the population at risk of developing the disease.
Measured: 1 year
Prevalence Percentage of Participants with CLL, MM and NHL
Prevalence of CLL, MM and NHL will be reported. Prevalence will be estimated using available population demographic information as the denominators and using the percentage of registered participants with those cancers at the sites as the numerators.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559583
- Sponsor's protocol ID
- CR105066
- Other IDs
- PCI-32765MMY4001
- Acronym
- HOLA
- Status last verified
- Jul 2016
- First submitted
- 23 Apr 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chiattone C, Gomez-Almaguer D, Pavlovsky C, Tuna-Aguilar EJ, Basquiera AL, Palmer L, de Farias DLC, da Silva Araujo SS, Galvez-Cardenas KM, Gomez Diaz A, Lin JH, Chen YW, Machnicki G, Mahler M, Parisi L, Barreyro P. Real-world analysis of treatment patterns and clinical outcomes in patients with newly diagnosed chronic lymphocytic leukemia from seven Latin American countries. Hematology. 2020 Dec;25(1):366-371. doi: 10.1080/16078454.2020.1833504.
PubMed 33095117
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemato-Oncology Latin America Observational Registry in CLL, Multiple Myeloma, Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02559583
- Acronym / sponsor ID
- HOLA / CR105066
- Conditions
- Multiple Myeloma, Leukemia, Lymphoid, Lymphoma, Non-Hodgkin
- Keywords
- Multiple Myeloma, chronic lymphocytic leukemia, Non-Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,443 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to quantify participants' demographic parameters, country standard therapies, treatment patterns and outcomes among participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America.
Detailed description
This is a retrospective (take a look back at events that already have taken place), non-interventional, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adult participants with a diagnosis of CLL, MM or NHL anytime since 01 January 2006. Only data available from clinical practice will be collected. All eligible participants at participating centers will be included regardless of participant's demographics, prior or current treatments for disease, or clinical outcome. The period of observation will span from 01 January 2006 through present, but all eligible participants must be followed for a minimum of 1 year, unless the participant died within that first year. Participant demographic parameters, standard therapies, treatment patterns and outcomes will be primarily quantified.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Chronic Lymphocytic Leukemia (CLL) | – | Other: Chronic Lymphocytic Leukemia (CLL)This is an observational study. Data will be captured for Participant's with diagnosis of Chronic Lymphocytic Leukemia according to hospital records in the questionnaire provided by the Sponsor. |
| Participants with Multiple Myeloma (MM) | – | Other: Multiple Myeloma (MM)This is an observational study. Data will be captured for Participant's with diagnosis of Multiple Myeloma (MM) according to hospital records in the questionnaire provided by the Sponsor. |
| Participants with Non-Hodgkin's lymphoma (NHL) | – | Other: Non-Hodgkin's lymphoma (NHL)This is an observational study. Data will be captured for Participant's with diagnosis of non-Hodgkin's lymphoma (NHL) data according to hospital records in the questionnaire provided by the Sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) in oncology concentration hospitals in Latin America
Key inclusion criteria (3 listed)
- Diagnosis of chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or non-Hodgkin lymphoma (NHL) anytime since January 1, 2006
- At least one year of data following first observed diagnosis except in the case of the participant death within one year following first observed diagnosis
- Participant must sign a participation agreement/informed consent form (ICF)
Key exclusion criteria (1 listed)
- Having one and only one consult in the center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Lymphocytic Leukemia (CLL)This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year. | Other | Participants with Chronic Lymphocytic Leukemia (CLL) |
| Multiple Myeloma (MM)This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year. | Other | Participants with Multiple Myeloma (MM) |
| Non-Hodgkin's lymphoma (NHL)This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year. | Other | Participants with Non-Hodgkin's lymphoma (NHL) |
Primary outcome
Number of Participants with Previous Comorbidities
Time frame: 1 year
Comorbidities included: heart, diabetes, hypertension, renal, infections, other neoplasia, neurologic, rheumatologic, HIV, thrombosis, bone and other.
Number of Participants as per treatment therapy received
Time frame: 1 year
Cancer treatment (Chronic Lymphocytic Leukemia [CLL], Multiple Myeloma [MM] and non-Hodgkin lymphoma [NHL]) for all participants is summarized by the number of participants who had any type of surgery or radiotherapy (external radiation or brachytherapy) or other drug treatments.
Overall survival
Time frame: 1 year
Overall Survival (OS) was defined as the time from date of starting treatment to death due to any cause.
Number of Participants with Response to Treatment
Time frame: 1 year
Number of participants who responded to treatment is presented. Treatment response will be assessed based on complete response or partial response.
2 secondary outcomes
Incidence Percentage of Participants with Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM) and non-Hodgkin lymphoma (NHL)
Time frame: 1 year
Prevalence Percentage of Participants with CLL, MM and NHL
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 33095117Chiattone C, Gomez-Almaguer D, Pavlovsky C, Tuna-Aguilar EJ, Basquiera AL, Palmer L, de Farias DLC, da Silva Araujo SS, Galvez-Cardenas KM, Gomez Diaz A, Lin JH, Chen YW, Machnicki G, Mahler M, Parisi L, Barreyro P. Real-world analysis of treatment patterns and clinical outcomes in patients with newly diagnosed chronic lymphocytic leukemia from seven Latin American countries. Hematology. 2020 Dec;25(1):366-371. doi: 10.1080/16078454.2020.1833504.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Leukemia, run by Janssen-Cilag Ltd. at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Brazil, Colombia, Mexico, Argentina, Panama and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Previous Comorbidities (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02559583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.